NCT04814420Recruiting
Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
The investigators hypothesize that Obstructive Sleep Apnea (OSA) is an independent risk factor for atrial fibrosis development. The investigators aim to prove the presence of atrial fibrosis on Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) in OSA patients without atrial fibrillation (AF).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 22 Mar 2021
- Start date
- 12 Jul 2021
- Primary completion date
- Nov 2026
- Lead sponsor
- Tulane University
- Diseases
- Atrial fibrillation
- NCT number
- NCT04814420
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 12 Jul 2021 to the primary completion date, Nov 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior cardiac or chest surgery.
Other illness
- Other advanced pulmonary disease (severe Chronic Obstructive Pulmonary Disease (COPD) or asthma, pulmonary hypertension) or central sleep apnea.
- Contraindications to DE-MRI (e.g. allergy to gadolinium, pacemakers, defibrillators (ICD's), other devices/implants contraindicated for MRI, glomerular filtration rate \<30 ml/min, etc.).
Lab values
- History of chronic heart failure (LVEF \< 50%), AF, myocardial infarction, valvular disease.
Other
- Pregnancy.
- Inability to give informed consent.
Who the study is looking for
- Group A: 10 patients 18-75-year-old With mild OSA (5\<AHI\<15), confirmed by polysomnography. No previous AF diagnosis on the medical chart
- Group B: 10 patients 18-75-year-old With moderate OSA (15\<AHI\<30), confirmed by polysomnography. No previous AF diagnosis on the medical chart
- Group C: 10 patients 18-75-year-old With severe OSA (AHI\>30), confirmed by polysomnography. No previous AF diagnosis on the medical chart
- Group D (mild OSA+ AF): 10 patients 18-75-year-old With mild OSA (5\<AHI\<15), confirmed by polysomnography. Previous AF diagnosis
- In this group, patients with AF and OSA who already have done MRI might be included.
- Group E (severe OSA +AF): 10 patients 18-75-year-old With severe OSA (AHI\>30), confirmed by polysomnography. Previous AF diagnosis
- \*In this group, patients with AF and OSA who already have done MRI might be included.
- Group F (Control): 10 Patients 18-75-year-old No previous OSA and/or AF Diagnosis on the medical chart
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| East Jefferson General Hospital Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| Tulane Doctors - Speciality Care - Napoleon Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.